Long Term Predictors of Acute Myocardial Infarction in Pa... | NCT06546228

Studies
Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization

NCT06546228

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Status

Completed

Last Update Posted

Aug 9, 2024Actual

Enrollment

652Actual

Phase

Not provided

Conditions

Acute Myocardial Infarction
Revascularization

Interventions

No intervention. Only observational.

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jul 12, 2024

First Submission Date that Met QC Criteria

Aug 7, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

652Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention. Only observational.	Other	Only collection of data or parameters already required by the medical examination programmed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Acute Myocardial Infarction (AMI)	Occurrence of AMI. Unit of measure: Medical records, electrocardiogram (ECG), cardiac biomarkers	7 years

Secondary Outcomes

Measure	Description	Time Frame
Change in Left Ventricular Ejection Fraction (LVEF)	LVEF before and after revascularization Measurement Tool: Echocardiogram Unit of Measure: Percentage (%) change in LVEF	7 years
Incidence of Cardiovascular Death

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients met the criteria for Acute Coronary Syndrome (ACS) as defined by the Joint European Society of Cardiology/American College of Cardiology Committee.
Patients underwent immediate coronary revascularization (primary PCI) for ST-Elevation Myocardial Infarction (STEMI).
Patients underwent coronary revascularization (early PCI) within 24 hours for Non-ST-Elevation Myocardial Infarction (NSTEMI).
Patients underwent diagnostic coronary angiography following coronary artery bypass graft surgery (CABG).

Exclusion Criteria:

Known coronary artery disease or previous ACS.
PCI following CABG.
Cardiogenic shock.
Atrial fibrillation.
Peripheral artery disease.
Severe cardiac valve disease.
Prosthetic aorta.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients hospitalized for acute coronary syndrome (ACS)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera Universitaria G. Martino		Messina			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Anonymous data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided